Senior Clinical Research Associate

🕒 il y a 1 mois

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

Cette entreprise a parrainé des visas de Travailleur Qualifié du Royaume-Uni par le passé.

👻 Score fantôme 27%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Pfizer

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1849

💼 Conseil

📣 Marketing

💊 Pharmaceutique

💰 Post-IPO Debt en 2023-05

Consulting • Marketing • Pharmaceuticals

Nous célébrons 175 ans d'innovation scientifique audacieuse - et nous n'avons pas encore terminé. Chaque jour, nous mettons notre passion et nos ressources au service de la mise au point de thérapies innovantes qui changent le visage des soins de santé. Surpassons hier.

Description

• Manage and monitor assigned investigator sites from site activation through database lock and closeout • Ensure clinical trials comply with monitoring plans, applicable laws, Good Clinical Practices, and Pfizer standards • Serve as primary contact for assigned investigator sites and manage investigator site relationships • Facilitate information flow among study team members, vendors, and investigator sites • Develop, coach, and train site personnel on protocols and compliance • Support enrollment and recruitment initiatives and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and serve as an unblinded monitor when appropriate • Maintain detailed understanding of products, protocols, and therapy areas • Support patient safety, eligibility, and clinical guidance to investigators • Drive quality event remediation and audit observation CAPA development when applicable • Mentor Clinical Research Associates when required

🎯 Exigences

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 3 years relevant experience in clinical research site monitoring • Some experience in Oncology • Global clinical trial experience • Fluency in English and the native language(s) of the country they will work in • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of monitoring, data acquisition and cleaning, reporting, and related operational elements • Knowledge of disease and technical areas pertaining to clinical studies, company direction, investigational products, and associated development plans • Ability to support sponsor regulatory interactions and inspections • Knowledge of protocol design and feasibility assessment processes • Understanding of regional/country culture and medical practice and their effects on clinical trial delivery • Ability to work in a matrix team environment and influence, drive/lead, and work through others • Ability to evaluate, interpret, and present complex issues and data for risk management and mitigation • Effective verbal and written communication skills • Ability to travel significantly within the area and occasionally internationally and on weekends

🏖️ Avantages

• Flexible workplace culture that encourages work-life harmony • Reasonable adjustments to support application and future career • Equal employment opportunity and diverse, inclusive workforce